# K111608: Slic Screw Repair System

- Pathway: 510(k) (Special)
- Applicant: Acumed, LLC
- Decided: Aug 29, 2011 after 81 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961498 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063244: Arc Surgical Bone Reduction Screw, Arc Surgical, LLC (2006) Summary page 2.

## Indications for use
The SLIC Screw Repair System is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.

Source page: https://510kreport.com/device/K111608
Methodology: https://510kreport.com/methodology